BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4100115 · Received September 18, 2014

    Report

    Report Number
    2953200-2014-01860
    Event Type
    Death
    Date Received
    September 18, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577912 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04222862

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Death